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Cisplatin, Bevacizumab, and Gemcitabine Followed by Surgery, Bevacizumab, and Paclitaxel in Treating Patients With Locally Advanced Nonmetastatic Bladder Cancer That Can Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00268450
Recruitment Status : Terminated
First Posted : December 22, 2005
Results First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving cisplatin, bevacizumab, and gemcitabine followed by surgery, bevacizumab, and paclitaxel works in treating patients with locally advanced nonmetastatic bladder cancer that can be removed by surgery.


Condition or disease Intervention/treatment Phase
Bladder Cancer Biological: bevacizumab Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: cysectomy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neo-Adjuvant Cisplatin, Gemcitabine & Bevacizumab, Followed by Radical Cystectomy for Patients With Muscle Invasive, Resectable, Non-Metastatic Transitional Cell Carcinoma (TCC) of the Bladder
Actual Study Start Date : September 21, 2005
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012


Arm Intervention/treatment
Experimental: study intervention
Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.
Biological: bevacizumab

Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles

After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles

Other Name: avastin

Drug: cisplatin
Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles

Drug: gemcitabine hydrochloride
Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles

Drug: paclitaxel
After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles

Procedure: cysectomy



Primary Outcome Measures :
  1. Complete Remission Rate [ Time Frame: From day of first treatment until after cycle 3 ]

Secondary Outcome Measures :
  1. Urinary Survivin Levels [ Time Frame: Baseline, week 6 and week 12 ]
  2. Urinary Cytogenitics [ Time Frame: baseline and week 12 ]
  3. Progression Free Survival [ Time Frame: from first treatment until time of progression or death, whichever comes first ]
  4. Median Overall Surivial [ Time Frame: from first treatment until death ]
  5. Percentage of Planned Dose Received [ Time Frame: from first treatment until end of week 12 ]
  6. Rate of Post-operative Complications [ Time Frame: from first treatment until up to 48 hours after surgery. ]


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell cancer (TCC) of the bladder

    • Staged as follows:

      • Muscle invasive (T2-T4a)
      • Node negative (N0)

        • No histologically or cytologically proven lymph node metastases
      • Nonmetastatic (M0)

        • No evidence of distant metastases
  • Resectable disease
  • Able to begin protocol treatment within 6 weeks after transurethral resection and cystoscopic evaluation
  • No central nervous system or brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status of 0-2
  • Karnofsky 60-100%
  • White blood cell count ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • AST(SGOT) and ALT(SGPT) ≤ 2 times upper limit of normal
  • Bilirubin ≤1.5 mg/dL
  • Creatinine clearance ≥ 60 mL/min
  • Urine protein/creatinine ratio < 1.0
  • Blood pressure ≤150/100 mm Hg
  • No prohibitive medical risks for chemotherapy
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, gemcitabine hydrochloride, or paclitaxel
  • No unstable angina
  • No history of myocardial infarction within the past 6 months
  • No cardiac arrhythmias
  • No New York Heart Association (NYHA) congestive heart failure ≥ grade 2
  • No history of stroke within the past 6 months
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No serious nonhealing wound, ulcer, or bone fracture
  • No psychiatric illness or other psychosocial situation that would limit ability to comply with study and/or follow-up procedures
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must agree to use adequate contraception prior to study entry and for the duration of study participation
  • No significant traumatic injury with in the past 28 days

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy
  • No prior pelvic radiation therapy
  • More than 4 weeks since prior participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
  • No concurrent participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
  • No major surgical procedure or open biopsy within the past 28 days
  • No anticipation of need for major surgical procedure during the course of the study
  • No minor surgical procedures, fine-needle aspirations, or core biopsies within the past 7 days
  • No concurrent treatment with hormones or other chemotherapeutic agents except the following:

    • Steroids given for adrenal failure
    • Hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
    • Intermittent use of dexamethasone as an antiemetic in solid tumor protocols
  • No other concurrent investigational or commercial agents or therapies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268450


Locations
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
McLeod Regional Medical Center
Florence, South Carolina, United States, 29501
Lowcountry Hematology and Oncology, PA
Mount Pleasant, South Carolina, United States, 29464-3233
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Study Chair: Andrew S. Kraft, MD Medical University of South Carolina
Study Chair: Gustavo Leone Medical University of South Carolina, Hollings Cancer Center

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00268450     History of Changes
Other Study ID Numbers: CDR0000454937
MUSC-AVF-3312
MUSC-HR-15537
GENENTECH-AVF-3312
MUSC-CTO-100892
First Posted: December 22, 2005    Key Record Dates
Results First Posted: July 12, 2018
Last Update Posted: July 12, 2018
Last Verified: May 2018

Keywords provided by Medical University of South Carolina:
transitional cell carcinoma of the bladder
stage III bladder cancer
stage II bladder cancer
recurrent bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Cisplatin
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs